- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01093014
Novel Intervention to Influence Muscle Plasticity in Veterans
Study Overview
Status
Conditions
Detailed Description
Central Hypothesis: The investigators hypothesize that high muscle force induced via a novel, portable, active standing intervention will increase muscle force properties, alter gene expression for atrophy and fiber type pathways, and improve systemic insulin sensitivity in Veterans with complete paralysis.
Aim 1: To determine the training effects of 3 tiers of quadriceps muscle force on muscle physiological properties in Veterans with chronic paralysis from SCI.
Aim 2: To determine the training effects of 3 tiers of quadriceps muscle forces on muscle mRNA for genes associated with atrophy and muscle fiber type in Veterans with complete paralysis.
Aim 3: To determine the training effects of 2 tiers of compressive load induced by quadriceps muscle forces on insulin sensitivity and markers of inflammation in Veterans with SCI.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Iowa
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Iowa City, Iowa, United States, 52246-2208
- Iowa City VA Health Care System, Iowa City, IA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inclusion criteria for all subjects will be upper motor neuron lesions between the 10th thoracic and the 7th cervical spinal levels. The completeness of the injury will be verified by somatosensory evoked potentials.
Exclusion Criteria:
- Subjects will be excluded if they have pressure ulcers
- chronic infection
- lower extremity muscle contractures
- deep vein thrombosis
- recent limb fractures
- muscle metabolic disorders
- any comorbid disease known to affect bone metabolism (such as parathyroid dysfunction)
- or if they are pregnant or plan to become pregnant.
- Subjects with distal femur trabecular bone mineral density less than 50 mg/cm3 will be excluded from participation in quadriceps electrical stimulation training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1: High-force muscle stimulation
High-force muscle stimulation
|
Electrical stimulation of paralyzed muscle in seated or standing to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
|
Experimental: Arm 2: Low-force muscle stimulation
Low-force muscle stimulation
|
Electrical stimulation of paralyzed muscle in seated or standing to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
|
Experimental: Arm 3: Sequential low-force and high-force muscle stimulation
Sequential low-force and high-force muscle stimulation
|
Electrical stimulation of paralyzed muscle in seated or standing to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HF Muscle Force
Time Frame: up to 1 year
|
Muscle force evoked during high-force muscle stimulation
|
up to 1 year
|
LF Muscle Force
Time Frame: up to 1 year
|
Muscle force evoked during low-force muscle stimulation
|
up to 1 year
|
Skeletal Muscle Gene Regulation: MSTN
Time Frame: up to 1 year
|
Messenger ribonucleic acid (mRNA) expression fold-change for myostatin (MSTN).
Fold change: post-intervention expression / pre-intervention expression.
Values greater than 1.0 indicate up-regulation.
Values less than 1.0 indicate down-regulation.
|
up to 1 year
|
Skeletal Muscle Gene Expression: PPARGC1A
Time Frame: up to 1 year
|
Messenger ribonucleic acid (mRNA) expression fold-change for peroxisome proliferator-activated receptor gamma, coactivator 1 alpha (PPARGC1A).
Fold change: post-intervention expression / pre-intervention expression.
Values greater than 1.0 indicate up-regulation.
Values less than 1.0 indicate down-regulation.
|
up to 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Richard K Shields, PhD PT, Iowa City VA Health Care System, Iowa City, IA
Publications and helpful links
General Publications
- Adams CM, Suneja M, Dudley-Javoroski S, Shields RK. Altered mRNA expression after long-term soleus electrical stimulation training in humans with paralysis. Muscle Nerve. 2011 Jan;43(1):65-75. doi: 10.1002/mus.21831.
- Kunkel SD, Suneja M, Ebert SM, Bongers KS, Fox DK, Malmberg SE, Alipour F, Shields RK, Adams CM. mRNA expression signatures of human skeletal muscle atrophy identify a natural compound that increases muscle mass. Cell Metab. 2011 Jun 8;13(6):627-38. doi: 10.1016/j.cmet.2011.03.020.
- McHenry CL, Shields RK. A biomechanical analysis of exercise in standing, supine, and seated positions: Implications for individuals with spinal cord injury. J Spinal Cord Med. 2012 May;35(3):140-7. doi: 10.1179/2045772312Y.0000000011.
- Dudley-Javoroski S, Shields RK. Regional cortical and trabecular bone loss after spinal cord injury. J Rehabil Res Dev. 2012;49(9):1365-76. doi: 10.1682/jrrd.2011.12.0245.
- Dudley-Javoroski S, Saha PK, Liang G, Li C, Gao Z, Shields RK. High dose compressive loads attenuate bone mineral loss in humans with spinal cord injury. Osteoporos Int. 2012 Sep;23(9):2335-46. doi: 10.1007/s00198-011-1879-4. Epub 2011 Dec 21.
- Petrie MA, Suneja M, Faidley E, Shields RK. Low force contractions induce fatigue consistent with muscle mRNA expression in people with spinal cord injury. Physiol Rep. 2014 Feb 25;2(2):e00248. doi: 10.1002/phy2.248. eCollection 2014 Feb 1.
- Petrie MA, Suneja M, Faidley E, Shields RK. A minimal dose of electrically induced muscle activity regulates distinct gene signaling pathways in humans with spinal cord injury. PLoS One. 2014 Dec 22;9(12):e115791. doi: 10.1371/journal.pone.0115791. eCollection 2014.
- Petrie M, Suneja M, Shields RK. Low-frequency stimulation regulates metabolic gene expression in paralyzed muscle. J Appl Physiol (1985). 2015 Mar 15;118(6):723-31. doi: 10.1152/japplphysiol.00628.2014. Epub 2015 Jan 29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B7097-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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